How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity

Description:

FDA The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.

This action is a milestone in consumer protection – going forward, the FDA will be able to:

• Review new tobacco products not yet on the market
• Help prevent misleading claims by tobacco product manufacturers
• Evaluate the ingredients of tobacco products and how they are made
• Communicate the potential risks of tobacco products

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco-related industries. Knowing the regulations is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

Why Should You Attend:

You should attend this seminar if you work in the tobacco or related industries and are responsible for manufacturing, labeling, marketing, distribution or other functions that are now, or soon will be, regulated by FDA.

You should attend if you work for a tobacco or related product company in the manufacturing, quality, information technology, marketing, or distribution areas. You should also attend if you are a retailer or own a vaping shop.

An effective and compliant strategy is critical to any FDA-regulated organization, including those in the tobacco and related product industries. Knowing the regulations is the first step toward ensuring compliance, and learning about industry best practices is a sure way to learn how to balance compliance with cost.

We’ll discuss the Tobacco Control Act (2009) and the Deeming Rule (2016). We’ll also cover the new draft requirements for the Premarket Tobacco Application (PMTA) based on the Tobacco Product Manufacturing Practices (TPMPs), the draft of which was issued by FDA in early 2023.

This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the ALCOA “plus” requirements for data integrity.

You will also learn about pending and potential regulations and where the tobacco and related product industries are heading in terms of compliance requirements.

Areas Covered in the Webinar:

• FDA Tobacco Control Act

• Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries

• Details of the August 8, 2016 FDA Regulation (“Deeming Rule”)

• Recent Trends in Regulation and the Future of Tobacco and Related Industries

• Premarket Tobacco Application (PMTA)

• Modified Risk Tobacco Product Application (MRTPA)

• Tobacco Product Manufacturing Practices (TPMPs)

• E-liquids, ENDS and Vaping Devices

• Compliance Strategy

• Cost vs. Compliance

• Industry Best Practices

• Policies and Procedures

• Leveraging Vendors

• FDA Trends

• Best Practices

• Q&A

Who Will Benefit:

Personnel in the following roles will benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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